Phototherapy For Treatment Of Raynaud's Phenomenon

To determine if blue light therapy can improve the symptoms of Raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.

Study Overview

• Status: Withdrawn
• Conditions: Raynaud Disease; Raynaud Phenomenon; Raynaud Syndrome
• Intervention / Treatment: Device: Blue Light Therapy; Device: Sham Light Therapy

Detailed Description

The purpose of this study is to test the efficacy of blue light phototherapy for the treatment of Raynaud's phenomenon (RP) in human participants. The specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that RP participants experience. This will be measured through the use of a visual analog scale (VAS) of both pain and numbness. This study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. Together, the visual analog scale (VAS) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced RP symptoms due to vasodilation of blood vessels.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome

Exclusion Criteria:

• Those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them.
• Inability of the subject to place their hands into the PTD portal because of physical size or discomfort.
• Inability of the subject to wear protective eyewear.
• Anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures.
• Females who are pregnant.
• Adults unable to consent for any reason not explicitly stated herein.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham First, then Experimental; Participants in this group will receive the sham treatment first, then the experimental treatment.	Device: Blue Light Therapy; This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.; Device: Sham Light Therapy; To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.
Experimental: Experimental First, then Sham; Participants in this group will receive the experimental treatment first, then the sham treatment.	Device: Blue Light Therapy; This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.; Device: Sham Light Therapy; To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) of Pain	Participants will be asked to rate their pain upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.	4 hours
Change in Visual Analog Scale (VAS) of Numbness	Participants will be asked to rate their numbness upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Temperature	Skin temperature of at least one finger will be measured and logged using a thermometer at multiple points during study visit. Outcome is reported in units of degrees Celsius.	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal Imaging	The thermal imaging camera takes still images of the hand before and immediately after treatment. It provides a heat map (color contour) that may be probed afterwards for temperature at designated points. These points are distributed over the fingers, hand and palms. A technician manually reads the temperature in degrees Celsius and enters the values into an Excel spreadsheet designating subject, ID and date; location of measurement; and other temperature readings. These include ambient (room temperature), and outside temperature. The finger and room temperatures, in Celsius, are electronically recorded on an Omega data logger. This is interrogated later to retrieve data. Another continuous reading is obtained of the temperature inside the hand compartment (separate from internal thermoregulation measurements) to track equipment functionality.	4 hours

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jerry Molitor, MD, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Raynaud Disease
• Other Study ID Numbers: RHEUM-2021-29567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No